Contaminant removal method
    2.
    发明授权

    公开(公告)号:US10730927B2

    公开(公告)日:2020-08-04

    申请号:US16041239

    申请日:2018-07-20

    Applicant: CSL Limited

    Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

    Contaminant removal method
    4.
    发明授权

    公开(公告)号:US10087235B2

    公开(公告)日:2018-10-02

    申请号:US14910424

    申请日:2014-08-08

    Applicant: CSL Limited

    Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nrn to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-f preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

    CONTAMINANT REMOVAL METHOD
    5.
    发明申请

    公开(公告)号:US20210147509A1

    公开(公告)日:2021-05-20

    申请号:US16945312

    申请日:2020-07-31

    Applicant: CSL Limited

    Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

    Process for preparing Apolipoprotein A-I (Apo A-I)

    公开(公告)号:US10421799B2

    公开(公告)日:2019-09-24

    申请号:US15870203

    申请日:2018-01-12

    Applicant: CSL LIMITED

    Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.

    PROCESS FOR PREPARING APOLIPOPROTEIN A-I (APO A-I)

    公开(公告)号:US20180298080A1

    公开(公告)日:2018-10-18

    申请号:US15870203

    申请日:2018-01-12

    Applicant: CSL LIMITED

    CPC classification number: C07K14/775 A61K38/00 A61K38/17 C07K1/30

    Abstract: The present invention relates to processes of obtaining Apo A-I from an Apo A-I containing protein fraction (A), comprising suspending the Apo A-I containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-I proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-I precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-I, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.

    Process for preparing apolipoprotein A-I (Apo A-I)

    公开(公告)号:US09890203B2

    公开(公告)日:2018-02-13

    申请号:US14893178

    申请日:2014-06-05

    Applicant: CSL LIMITED

    CPC classification number: C07K14/775 A61K38/00 A61K38/17 C07K1/30

    Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending—the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.

    Contaminant removal method
    10.
    发明授权

    公开(公告)号:US11732028B2

    公开(公告)日:2023-08-22

    申请号:US16945312

    申请日:2020-07-31

    Applicant: CSL Limited

    CPC classification number: C07K14/775 C07K1/34 A61K38/00

    Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.

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